Sensorion is recruiting a Head of Clinical Operations F/M based on Paris.
Reporting to the Chief Medical Officer, the Head of Clinical Operations will be responsible for all the aspects of clinical trial delivery, from study set-up to end of study, including all logistical, financial, administrative and organisational aspects.
Responsibility and monitoring of clinical activities:
- Supervise the sites’ selection and qualification in collaboration with the CRO and the Medical department
- Optimization of patients‘ recruitment in clinical studies
- Supervise the creation of specific trial documents, validate them and ensure their implementation, including recruitment plan
- Establish the different agreements and / or contracts required for studies according to the processes in place.
- Review of the different agreements and / or contracts with sponsor, vendors, suppliers, hospital…(master service agreements, statement of work, quality agreements…) relating to clinical operations.
- Implement best practices and standards for trial management in collaboration with other members of the clinical operations team and the quality department, including development of SOPs.
- Validate the clinical trials support documents (monitoring guide according to the risk- based approach, logistic procedures).
- Ensure that clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.
- Plan clinical headcount and hiring needs to meet program workload demands.
- Ensure study issues and action items are addressed and closeout appropriately and in compliance with study management plans.
- Study budget management and oversight of vendor and site payments in collaboration with the Clinical Project Manager.
- Supervise the processes for studies’ budget follow-up and control with the finance team;
- Prioritization and reallocation of means / resources (human, financial, deadlines, materials…) according to the results and the strategy;
- Planning of clinical studies;
- Lead, motivate and mobilize a team of multidisciplinary collaborators;
- Optimize the organization of work, work processes, the means used, plan and evaluate the results;
- Human resources management of clinical operations department (recruitment, evaluation, training…);
- Define priorities for action and allocation of means / resources / deadlines;
- Evaluate, develop and recognize the collaborators of his/her organization;
- Know how to prevent and / or prioritize possible conflicts and tensions.
- State Diploma of Doctor of Medicine or equivalent.
- 5+ years Pharmaceutical drug development industry experience, in rare diseases programs, including a thorough understanding of drug development in early phase trials.
- 5 years+ experience as clinical operations in a similar position. Proven success in leading and coordinating cross-functional clinical operations teams. (e.g., clinical operations, data management, clinical supply chain).
- Clinical trial management experience (specifically in rare diseases) highly preferred.
- Experience managing CROs and vendors throughout entire clinical operations life cycle.
- Functional management experience required.
- Excellent level of English and French is mandatory.
Several incidents involving organizations and individuals claiming to be fraudulently recruiting on behalf of Sensorion have recently been identified.
The objective of the fraudsters is to extort money from applicants by requesting additional expenses (medical devices, travel agency, visa fees, etc.) or obtaining personal data (bank details, address, etc.). Please note that Sensorion, its subsidiaries or the recruitment firms they appoint during the hiring process do not request financial contributions or bank details from candidates under any circumstances.
We take this situation very seriously and are taking all possible actions to identify and put an end to this type of fraud.
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